Initial procedure of mini ThoracOthomic ablation of Persistent Atrial Fibrillation versus percutaneous catheter approach

Completed

• Conditions: Persistent Atrial Fibrillation as defined by the 2012 Focused Updated of the ESC guidelines for the management of AF. Europ Heart J (2012)33:2719; Circulatory System; Atrial fibrillation and flutter

• Registration Number: ISRCTN08035058
• Lead Sponsor: The Catholic University of the Sacred Heart (Università Cattolica S. Cuore Roma) (Italy)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-20
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

The inclusion and exclusion criteria, definitions and treatment protocols are those reported by the 2012 HRS/EHRA/ECAS expert consensus statement on cathter and surgical ablation of atrial fibrillation. J Interv Card Elecrophysiol (2012);33:171
Inclusion criteria
1. Patients who are 18 years of age or older
2. Patients with persistent AF, which is defined as a sustained episode lasting more than 7 days in the last 12 months
3. Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication. Symptomatic patients are those who have been aware of their AF at anytime within the last 5 years before enrollment. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms, or any combination of the above.
4. At least one episode of persistent AF must have been documented by ECG, Holter, loop recorder, telemetry, transtelephonic monitor, or implantable device within last 2 years of enrollment in this investigation.
5. Patients must be able and willing to provide written informed consent to participate in this investigation
6. Patients must be willing and able to comply with all periablation and follow-up requirements

Exclusion Criteria

1. Patients with paroxysmal AF, whic is defined as a sustained episode lasting >7 days
2. Patients with long-standing persistent AF, which is defined as a sustained episode lasting >1 year
3. Patients for whom cardioversion or sinus rhythm will never be attempted/pursued
4. Patients with AF secondary to a reversible cause
5. Patients with contraindications to systemic anticoagulation
6. Patients with left atrial size =55 mm (2-dimensional echocardiography, parasternal long-axis view)
7. Patients with LA thrombi as demonstrated by TEE

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Freedom from AF at 12 months as detected by a 12 leads ECG and a 24 H Holter examination after a 3, 6 and 9 months follow-up <br>2. A repeated procedure to achieve a 12 months freedom from AF

Secondary Outcome Measures

Name	Time	Method
Any documented atrial arrhythmia like atrial fibrillation (AF) or a trial flutter (AFL) or atrial tachycardia (AT)